In the pharmaceutical, biotechnology and even food, beverage and cosmetic industries, it is often desired to provide large scale processing systems that are capable of handling fluids in a sterile manner. These large scale processing systems are designed to prevent unwanted and often dangerous organisms, such as bacteria, as well as unwanted and potentially harmful environmental contaminants, such as dust, dirt and the like from entering into the process stream and/or end product. In order to prevent these types of outside contaminants from entering these systems it is desirable to have a completely sealed processing system. However, completely closed processing systems are not always possible since there is a need for the introduction or removal of materials from the process stream in order to add components of the product, such as media or buffers to a bioreactor; withdraw samples from the process stream to check for microbial contamination, quality control, process control, etc; and to collect the product into its final container such as vials, syringes, sealed boxes, bottles and the like.
Traditionally, processing systems have been made of stainless steel, wherein the stainless steel systems are exposed to live steam before use, and then cleaned with chemicals such as caustic solutions after use, to ensure that all contaminants and the like are removed. Steaming is the most effective means of sterilization. The use of steam in a set system is known as steaming in place or SIP. Saturated steam carries 200 times the BTU heat transfer capacity of heated air because of the latent heat released by the steam as it changes from vapor to liquid.
However, several disadvantages exist with the use of steam. Any connection to, or opening of, the processing system made after the system has been steamed in place is an aseptic (but not sterile) connection or opening. This increases the risk of contamination of the entire system. Typically alcohol wipes or an open flame are used to clean the components intended to be connected to the system, (e.g., connecting a sample collection bag to a system after SIP has occurred) and thus minimizes the risk of contamination.
Also, the high temperatures and pressure differentials associated with steam make the selection of filter materials and other components difficult and limited. Additionally, accidental pressure differential at high temperatures can cause a filter, membrane or other non-steel component to fail.
Processing systems that are reused need to undergo rigorous testing and validation to prove to the necessary regulatory authorities that the system is sterile before each use. The validation process and the required cleaning regiment of a previously used system are expensive and time consuming, typically taking up to 1 to 2 years for approval. In addition, certain components are difficult to adequately clean after use in preparation for their next use. Since manufacturers are often looking for ways to reduce both the costs and the time to market for their products, one possible approach at reducing costs and time to market for a product is to adopt an all disposable system that is set up in a sterile fashion, used once and then discarded.
Another possible approach to alleviating the time and expense associated with a systems' cleaning regiment is the use of disposable components for certain reusable components that are more expensive and/or time consuming to clean than other components.
Additionally, disposable components that are used in place of time consuming to clean reusable components should be easy to remove and replace. For example, the ease with which large scale disposable fluid transfer devices, such as valves or connectors, can be removed and replaced, and the manner in which large scale disposable assemblies are integrated into traditional stainless steel processing systems via disposable fluid transfer devices, have the potential to reduce processing costs and improve the efficacy and productivity of these systems.